Issued by
National Center for Advancing Translational Sciences (NCATS)

Purpose

The National Center for Advancing Translational Sciences (NCATS) is soliciting new molecular entities (NMEs) and biologics that are Phase 2-ready for use in the NIH-Industry New Therapeutic Uses Program. The New Therapeutic Uses program will explore new indications drug candidates (Agents) across a broad range of human diseases. This NIH initiative is a continuation of the pilot program (PAR-12-203, RFA-TR-12-004, RFA-TR-12-005). NCATS hopes to expand the Program to include additional pharmaceutical company partners and compounds. This innovative Program will allow investigators from the biomedical research community to propose new therapeutic uses for these compounds from participating pharmaceutical company partners as it did for the pilot program.

Through this Notice, NIH is inviting prospective pharmaceutical companies to partner with NCATS and expand the Program. In order to participate in this Program, the following criteria must be met:

At least 3 compounds will be contributed for the solicitation

Mechanism of action for each compound must be known

Pharmacokinetics are suitable to explore the mechanism in a new indication

Company will provide pre-clinical and clinical supply for studies (both drug and placebo)

Company must have available the appropriate regulatory documents (i.e., cross reference letter or study reports) to enable a funded investigator to file an Investigational New Drug application in the U.S. within one (1) month of NIH funding

Agents currently in clinical development can be included

A Memorandum of Understanding (MOU) (example of what was used for the pilot: http://www.ncats.nih.gov/files/MOU-template.pdf ) between NCATS and each of the pharmaceutical company partners will define the activities to be conducted under the Program.